India 'privately' against patent-overriding drug permits

Indian government has "privately reassured" industry lobby group US-India Business Council that the country would not invoke 'compulsory licensing' for commercial purposes that could allow local drugmakers to make cheaper products by overriding patents of big global players.

New Delhi: Indian government has "privately reassured" industry lobby group US-India Business Council that the country would not invoke 'compulsory licensing' for commercial purposes that could allow local drugmakers to make cheaper products by overriding patents of big global players.

The US-India Business Council, however, wants the Indian government to make "a public commitment" to forego using compulsory licensing for commercial purposes and use this clause for public emergencies only, the advocacy group has said in a submission to the US Trade Representative.

As per the WTO agreement, a compulsory license can be invoked by a national government to allow someone else to produce a patented product or process without the consent of the patent owner. It is done for the cause of public health.

"Despite compulsory licensing denials, industry continues to be concerned by the potential threat of compulsory licensing. The Government of India has privately reassured... (that) it would not use Compulsory Licenses for commercial purposes," the USIBC said in its submission.

The submission was made last month by USIBC to the Office of the US Trade Representative and is addressed to Acting Assistant United States Trade Representative, Intellectual Property and Innovation Probir Mehta.

It further said that USIBC would be further encouraged if the Government of India made a public commitment to forego using compulsory licensing for commercial purposes and in public emergencies only, saying "it would greatly enhance legal certainty for innovative industries".

No immediate comments were available from the concerned authorities in this regard.

The Indian Patent Office had invoked such a clause for the first time in March 2012 to permit Hyderabad-based Natco Pharma to manufacture and sell cancer-treatment drug Nexavar at a fraction of the price charged by its patent-holder Bayer Corporation.

The order, which provided great relief to the kidney and liver cancer patients, was issued by India Patents Office as a 'Compulsory Licence' under Section 84 of the Indian Patent Act, which is in compliance with the TRIPS agreement of the World Trade Organisation.